MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 142730490

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Event Description

The event involved a plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in in which the customer reported that the clave additive port snapped off.There was patient involvement but no patient harm.That the status of the product at the time of the event was during infusion.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is not yet received.E1 - ext.(b)(6).

Manufacturer Narrative

Received one used 142730490 plum 150 ml burette set for inspection on (b)(6) 23.As received, the clave port of the upper lid of the burette was observed to be broken.The adapter of the clave remained bonded in the bond pocket of the upper lid.The broken portion of the tip was examined.The shape of the deformation was angled where one sided is higher than the other, typical of a bend break.The deformation observed was in the form of beach marks on the higher portion of the angled break on tip.The opposite lower side was smoother.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18166244
• MDR Text Key: 328969201
• Report Number: 9615050-2023-00657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)260801(10)13702506
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142730490
• Device Lot Number: 13702506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1